Variable angle orthopedic fasteners for fixation of an orthopedic implant

ABSTRACT

Systems for variable angle insertion of surgical fasteners relative to an orthopedic plate with locking of the surgical fastener relative to the plate upon insertion. The systems may include a pivot member secured relative to either the orthopedic plate or the fastener. In either regard, the pivot member may provide locking engagement with the plate to lockingly engage the fastener relative to the plate.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/628,638 filed on Jan. 3, 2020, entitled “VARIABLE ANGLE ORTHOPEDICFASTENERS FOR FIXATION OF AN ORTHOPEDIC IMPLANT,” which is a NationalStage Application under 35 U.S.C. § 371 of International Application No.PCT/US2018/033730, filed on May 21, 2018, entitled “VARIABLE ANGLEORTHOPEDIC FASTENERS FOR FIXATION OF AN ORTHOPEDIC IMPLANT,” whichclaims the benefit of U.S. Provisional Patent Application No. 62/509,279filed May 22, 2017, entitled “VARIABLE ANGLE ORTHOPEDIC FASTENERS FORFIXATION OF AN ORTHOPEDIC IMPLANT,” which is incorporated herein byreference in its entirety.

FIELD

The present disclosure generally relates to orthopedic hardware, and inparticular to plates and screws for fixation of orthopedic hardwarerelative to the bone of a patient.

BACKGROUND

In many orthopedic surgeries, various types of hardware may be affixedto a bone of a patient. For instance, orthopedic plates may be used forfixation of bones that have been fractured. A variety of plate types maybe provided for use in different contexts. In certain instances, a platetype may be particular to a given anatomical use and/or plate function.In any regard, most often such plates are affixed to the bone of apatient using surgical fasteners such as bone screws.

In some approaches to affixing an orthopedic plate to a bone, it may bedesirable to provide flexibility in relation to the angle at which thefastener or screw used to secure the plate to the bone is disposedrelative to the plate. For example, it may be desirable to allow forscrews to be inserted at various different angles in relation to a platefor different plate applications. However, previously contemplatedfasteners and fastener systems include drawbacks that limit theapplicability and/or effectiveness of such systems when providingflexibility in relation to the angle at which a screw is advancedrelative to a plate for securing a plate to a bone of a patient.

In this regard, a number of systems have been proposed to allow for ascrew to be inserted at variable different angles relative to the plate.In such contexts, it may be desirable to provide locking screws thatinclude head portions that are secured to the plate upon insertion ofthe screw into the bone. As will be seen in the discussion below,provision of a locking screw system that is efficient to use, allows forvariable angulation of the screw relative to the plate, and provides forgood patient outcomes has yet to be adequately provided.

Some proposed systems include multiple, separately provided pieces thatmust be manipulated and arranged by the surgeon prior to or at the timeof screw insertion. In this regard, the surgeon is required tomanipulate a number of parts in relation to screw insertion, which maybe particularly difficult when screw insertion is provided in awkwardpositions relative to the anatomy of the patient. Moreover, thepotential for loss of one or more of these parts exists, which mayincrease foreign body exposure in the surgical site.

In other proposed approaches, the plate through which the screw passesduring insertion may comprise a relatively softer material than thescrew. In this regard, the screw head is provided with threads that cutinto the plate to tap threads as the screw is advanced relative to theplate, thus locking the screw to the plate. That is, the screw mayprovide self-tapping of the relatively softer material to engage theplate to lock the screw to the plate. However, in this approach, thepotential for metal shavings to be produced as the screw head self-tapsto the plate. While efforts may be undertaken to remove such metalshavings, any remaining shavings may remain that may result in softtissue damage. Moreover, after insertion (e.g., during the healingprocess), this approach may result in cold fusion to occur between thescrew head and the plate. In turn, when removing the plate, it may benecessary to use alternative techniques for screw removal other thansimply unscrewing the screw from the plate and bone. For instance, thescrew may be required to be drilled to remove the screw from the plateand a complicated screw removal process may be undertaken.

SUMMARY

In view of the foregoing, improved orthopedic hardware systems areneeded that facilitate variability in relation to the angle at whichfasteners are advanced relative to a plate to secure the plates to abone of the patient. Specifically, a persistent need exists inorthopedic systems that allows for a screw to be used to secure a plateto a bone such that the screw may be positioned with variable angulationrelative to the plate in a manner that is functional, efficient, safe,and allows screw removal.

Specifically, embodiments described herein may facilitate locking afastener to a plate such that the fastener may be positioned indifferent relative angles relative to the plate. In turn, a pivot membermay be provided that facilitates locking interaction between a fastenerand a plate. However, unlike previous systems in which a separatecomponent is provided to facilitate such locking interaction, thepresent disclosure contemplates an efficient, easy to use system inwhich components are secured so as to provide a traditional workflowduring surgery. That is, the pivot member may be restrainedly engagedwith the plate or the fastener such that a surgeon need not separatelymanipulate a third component beyond the plate and fastener.

In at least some of the embodiments described herein, when a fastenerhas been used for fixation of a plate to a bone, the fastener may belocked to the pivot member that is in turn locked to the plate. Forinstance, the fastener may include threads on a head portion thereofthat engage corresponding threads provided on the pivot member.Accordingly, the threaded engagement between the head portion of thefastener and the pivot member may result in locking interaction betweenthe pivot member and the fastener. In addition, the head portionengaging the pivot member may result in radial expansion of the pivotmember, which may frictionally engage a sidewall of an aperture in theplate to lock the pivot member with respect to the plate. In thisembodiment, the fastener may engage the bone of a patient and the plateso that the plate is not loaded in compression relative to the bone ofthe patient. In this regard, the resistance to shearing forces may besignificantly improved. Specifically, when a locking screw thatthreadably engages the pivot member is used, the screw may be engagedwith shearing forces along an entire length of the screw so as increasethe resistance to shearing forces of the screw. In alternativeembodiments, conventional screws may be used that load the pivot memberand plate in compression for securing the plate relative to the bone ofthe patient.

In other embodiments, a fastener assembly may be provided in which thepivot member is securely retained relative to the fastener. In thisregard, as the fastener is advanced relative to a plate for fixation ofthe plate relative to a bone of a patient, the pivot member may bedisposed relative to the plate. Once the pivot member is disposedrelative to the plate (e.g., relative to an aperture in the plate as aresult of the advancement of the fastener relative thereto), the pivotmember may lockingly engage the plate to secure the fastener relative tothe plate.

Various approaches to locking the pivot member relative to the plate aredescribed here. For instance, the pivot member may be configuredrelative to the fastener for co-rotation therewith. As an example, thepivot member may be correspondingly shaped relative to a non-circularprofile of the fastener such that the pivot member co-rotates with thefastener. IN turn, upon rotational advancement of the fastener, thepivot member may also be rotated relative to the plate to engage lockingfeatures on the fastener and plate to lockingly engage the pivot memberto the plate. Alternatively, the pivot member may be independentlyrotatable relative to the faster. As such, once the fastener is advancedrelative to the plate, the pivot member may be independently rotated toengage locking features between the fastener and plate. Further still,the fastener may include features that allow for engagement of the pivotmember to lockingly engage the fastener and pivot member to the plate.For instance, a head portion may be moveable to engage a ramped surfacewith the pivot member to radially expand the pivot member intofrictional engagement with an aperture of the plate.

In view of the foregoing, a first aspect includes an orthopedic plate.The plate includes a plate body extending between an upper surface and alower surface of the plate body. The plate also features an apertureextending through the plate body from the upper surface to the lowersurface along a reference axis. The aperture has a sidewall extendingcircumferentially about an interior of the aperture. The plate includesa pivot member that is retained within the aperture. The pivot memberincludes an outer surface corresponding to the sidewall of the aperture.The pivot member defines a bore extending along a fastener insertionaxis. The bore is configured to accept a fastener along the fastenerinsertion axis. In turn, the pivot member is disposable between a firstconfiguration that allows relative movement between the outer surfaceand the sidewall and a second configuration in which the outer surfacefrictionally engages the sidewall to restrict movement of the pivotmember relative to the aperture. The pivot member is displaceablerelative to the plate body within the aperture when in the firstconfiguration to define an included angle between the reference axis andthe insertion axis.

A number of feature refinements and additional features are applicableto the first aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thefirst aspect.

For instance, the second configuration of the pivot member may includeradial expansion of the pivot member to frictionally engage the sidewallwith the outer surface. In an embodiment, at least one of the bore or ahead portion of the fastener disposed within the bore may include asloped surface such that the head portion and the bore are engageableupon receipt of the fastener in the bore to cause the radial expansion.That is, the sloped surface of the head portion and/or bore may bedisposed such that as the head portion is engaged with the pivot member(e.g., through threadable and/or compressive engagement), the pivotmember may radially expand. As such, the pivot member may include anexpansion slot that allows for the radial expansion of the pivot memberradially relative to the fastener insertion axis. The expansion slot mayextend through the pivot member in a direction along the insertion axis.In an embodiment, the slot may extend entirely through the pivot memberin a direction along the insertion axis. That is, the pivot member maybe split to facilitate radial expansion thereof. In other embodiments, aplurality of expansion slots may be provided that may be spaced aboutthe pivot member. The plurality of expansion slots may extend partiallythrough the pivot member to facilitate radial expansion of at least aportion of the pivot member.

In an embodiment, the aperture may include a non-circular sidewallportion and the outer surface of the pivot member may be engageable bythe non-circular portion to inhibit rotation of the pivot member aboutthe reference axis. As such, when the fastener is rotatable advancedrelative to the pivot member, the pivot member may not rotate about thefastener insertion axis. The pivot member comprises a plurality of flatsextending about the perimeter of the pivot member and the non-circularsidewall is correspondingly shaped flat portions. In an embodiment, thepivot member may be a substantially hexagonal member similar to commonlyprovided nuts. The aperture may include a ramped surface of a flangeextending relative to the aperture that engages a convex portion of thepivot member. The pivot member may also include chamfers extendingbetween the plurality of flats to facilitate unrestricted pivotalmovement of the pivot member relative to the plate in two degrees offreedom. That is, in a traditional hexagonally shaped nut, pivotalmovement within the aperture may be restricted due to interferencebetween the flats of the nut and the sidewall. Providing chamfersbetween the flats of the pivot member may reduce or eliminate suchinterference, allowing the pivot member to pivot freely within theaperture.

In an embodiment, the plate may facilitate engagement of the fastenerand the plate such that the fastener is loaded without compressionforces. For instance, the bore may include threads adapted to engagecorresponding threads on a head portion of the fastener. In this regard,by threadably engaging the pivot member with the head portion of thefastener, the fastener may be loaded without compression. It has beenfound that such absence of compression loading of a fastener may allowfor greater resistance to shear forces or other forces (e.g., axialforces, tensile forces, bending moments, etc.) acting between the plateand the fastener as the plate is loaded (e.g., as a result of anatomicalmovement or the like).

In an embodiment, the included angle between the reference axis and thefastener insertion axis may be definable in at least one degree offreedom when the pivot member is in the first configuration. Theincluded angle between the reference axis and the insertion axis may bedefinable in at least two degrees of freedom. The included angle betweenthe reference axis and the fastener insertion axis is definable at anyradial position about the reference axis. The included angle between thereference axis and the insertion axis may be at least about 10 degrees.Alternatively, the included angle between the reference axis and theinsertion axis may be at least about 15 degrees.

The pivot member may be irremovably provided within the aperture. Inthis regard, the plate body may include extensions adjacent to the uppersurface and extending relative to the aperture. The extensions mayoriginally be positioned to allow for passage of the pivot member intothe aperture. Thereafter, the extension members may be moved to securethe pivot member in the aperture. That is, the extensions may bedisplaceable into position to extend relative to the aperture uponreceipt of the pivot member into the aperture to secure the pivot memberwithin the aperture. As such, the extensions may extend relative to theaperture to retain the pivot member in the aperture. Such extensions mayextend parallel to a surface of the plate or may extend in a directionnormal to the surface of the plate. In this regard, the extensions maycomprise flanges that extend normal to the surface of a plate to allowthe pivot member to be disposed in the aperture, such that the flangesare moved into a parallel position relative to the surface of the plateto secure the pivot member. Alternatively, the extensions may extendparallel to the surface of the plate and define a hole through which thepivot member may be passed through in a collapsed or retracted state.Once through the hole and in the aperture, the pivot member may beexpanded such that the extensions maintain the pivot member securelywithin the aperture.

A second aspect includes an orthopedic system for fixation of anorthopedic plate to a bone of a patient. The system may include a platebody extending between an upper surface and a lower surface of the platebody. An aperture may be provided that extends through the plate bodyfrom the upper surface to the lower surface along a reference axis. Theaperture has a sidewall extending circumferentially about an interior ofthe aperture. The system also includes a pivot member retained withinthe aperture. The pivot member includes an outer surface correspondingto the sidewall. The pivot member also defines a bore extending along afastener insertion axis. The pivot member is displaceable relative tothe plate body within the aperture to define an included angle betweenthe reference axis and the fastener insertion axis. The system alsoincludes a fastener that includes an elongate portion and a headportion. The elongate portion extends along an insertion axis defined bythe pivot member bore and the head portion is engaged with the pivotmember to radially expand the pivot member to frictionally engage thesidewall with the outer surface to restrict displacement of the nutwithin the aperture relative to the plate body.

A number of feature refinements and additional features are applicableto the second aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thesecond aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first aspect may be utilized inany combination with the second aspect.

In an embodiment of the second aspect, the elongate portion of thefastener may engage the bone of a patent to compressingly engage thehead portion relative to the pivot member to expand the pivot memberradially relative to the insertion axis. As may be appreciated, this maybe provided as an alternative to the threaded engagement described abovein which the fastener is loaded without compression forces actingthereon.

A third aspect includes a method of use of an orthopedic system. Themethod includes placing a plate body that extends between an uppersurface and a lower surface relative to a bone of a patient such thatthe lower surface is in contacting engagement with the bone of thepatient. The plate body includes an aperture extending through the platebody from the upper surface to the lower surface along a reference axisand includes a pivot member retained within the aperture that defines abore extending along a fastener insertion axis. The method includesarticulating the pivot member relative to the plate body to define anincluded angle between the reference axis and the fastener insertionaxis. The method also includes disposing an elongate portion of afastener through the bore of the pivot member such that the fastener isadvanced along the insertion axis and advancing the fastener relative tothe pivot member such that a head portion of the fastener engages thepivot member. The method further includes expanding the pivot memberradially relative to the fastener insertion axis in response to theadvancing such that the pivot member frictionally engages the apertureto restrict articulation of the pivot member relative to the plate body.

A number of feature refinements and additional features are applicableto the third aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thethird aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first or second aspects may beutilized in any combination with the third aspect.

For instance, the pivot member may include an expansion slot and theexpanding may include expanding the nut relative to the expansion slot.The expanding may also include contacting a sidewall of the aperturewith an outer surface of the pivot member.

In addition, the advancing may also include engaging threads on the headportion of the fastener with corresponding threads disposed on the boreof the pivot member. In turn, the method may include locking the headportion of the fastener to the pivot member in response to the engagingof the threads on the heads with the threads disposed on the bore of thepivot member.

In an embodiment, the articulating may include movement of the pivotmember in the aperture relative to the plate body in at least one degreeof freedom. The articulating may include movement of the pivot member inthe aperture relative to the plate body in at least two degrees offreedom. The articulating may include movement of the pivot member inthe aperture relative to the plate body such that the included angle isdefinable at any radial position about the reference axis. The includedangle between the reference axis and the insertion axis may be at leastabout 10 degrees. The included angle between the reference axis and theinsertion axis may be at least about 15 degrees.

A fourth aspect includes an orthopedic fastener assembly for use infixation of an orthopedic plate to a bone of a patient. The assemblyincludes a fastener that includes an elongate portion and a headportion. The elongate portion is on a distal portion of the fastener andincludes threads for engagement with a bone of a patient. The headportion is disposed at a proximate portion of the fastener. The assemblyalso includes a pivot member that includes a bore having a contouredsurface disposed about and pivotally displaceable relative to the headportion for pivotal articulation of the pivot member about the headportion. The pivot member is moveable relative to the head portion andsecured thereto to prevent removal of the pivot member from the headportion.

A number of feature refinements and additional features are applicableto the fourth aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thefourth aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through third aspects maybe utilized in any combination with the fourth aspect.

For instance, the bore may define a reference axis and the fastener mayextend along a fastener insertion axis. In turn, the pivotalarticulation of the pivot member about the head portion may define anincluded angle between the reference axis and the fastener axis. Theincluded angle between the reference axis and the fastener insertionaxis may be definable at any radial position about the reference axis.The included angle may be at least about 10 degrees. The included anglemay alternatively be at least about 15 degrees.

In various embodiments, the pivot member may include engagement featuresto lockingly engage the pivot member to a plate through which thefastener has been advanced. For instance, in an embodiment, thecontoured surface and the head portion may be non-circular and interfaceto restrict rotation of the pivot member about a fastener insertion axisextending along the elongate portion. In turn, the pivot membercomprises a first locking feature that correspond to and are engageablewith a second locking feature on a plate through which the fastener isadvanceable. The first locking feature may include a ramped surfaceengageable with corresponding teeth on a plate through which thefastener is advanceable to allow for rotation of the pivot member in afirst direction relative to the plate and to restrict rotation in asecond direction opposite the first direction when the ramped surfaceengages the corresponding teeth on the plate. The contoured surface maybe circumferentially arcuate about the bore and the pivot member isrotatable about the head portion about the fastener insertion axis.

In an alternative embodiment, the first locking feature may include aramped surface engageable with a corresponding shoulder on a sidewall ofan aperture extending through a plate through which the fastener isadvanceable. The ramped surface may be rotationally displaceablerelative to the shoulder to lockingly engage the pivot member relativeto the plate. The bore of the pivot member may further include a slopedsurface extending away from the locking axis in a proximal direction. Inturn, coordinated engagement of the ramped surface and the shoulder mayurge the pivot member proximally to lockingly engage the pivot memberrelative to the plate in response to rotation of the pivot member in afirst rotational direction. In addition, the shoulder may include a lipfor coordinated engagement of a trailing edge of the ramped surface torestrict rotation of the pivot member in a second rotational directionopposite the first rotational direction.

A fifth aspect includes an orthopedic system for use in fixation of anorthopedic plate to a bone of a patient. The system includes a fastenercomprising an elongate portion on a distal portion of the fastener. Theelongate portion includes threads for engagement with a bone of apatient and a head portion at a proximate portion of the fastener. Thefastener extends along a fastener insertion axis. The system alsoincludes a pivot member comprising a bore that defines a locking axis.The bore includes a contoured surface disposed about and pivotallydisplaceable relative to the head portion for non-removable engagementtherewith. The contoured surface is moveable relative to the headportion for articulation of the pivot member relative to the headportion to define an included angle between the locking axis and thefastener insertion axis. The pivot member comprises a first lockingfeature. The system also includes a plate extending between an uppersurface and a lower surface and having an aperture extending through theplate from the upper surface to the lower surface along a referenceaxis. The aperture comprises a second locking feature. In turn, thelocking axis is alignable with the reference axis as the fastener isadvanced relative to the plate along the fastener insertion axis and thefirst and second locking features are engageable upon rotational of thepivot member relative to the plate to engage the pivot member with theplate to prevent rotational retraction of the pivot member. When engagedwith the plate, the pivot member maintains the included angle betweenthe fastener insertion axis and the locking axis.

A number of feature refinements and additional features are applicableto the fifth aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thefifth aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through fourth aspectsmay be utilized in any combination with the fifth aspect.

For instance, in an embodiment, the included angle between the lockingaxis and the fastener insertion axis may be definable at any radialposition about the reference axis. The included angle may be at leastabout 10 degrees. Alternatively, the included angle is at least about 15degrees.

In an embodiment, the contoured surface and the head portion may benon-circular and may interface to restrict rotation of the pivot memberabout a fastener insertion axis extending along the elongate portion. Inturn, the pivot member may include a first locking feature thatcorrespond to and are engageable with a second locking feature on theplate. The first locking feature may include a ramped surface engageablewith corresponding teeth on the plate to allow for rotation of the pivotmember in a first direction relative to the plate and to restrictrotation in a second direction opposite the first direction when theramped surface engages the corresponding teeth on the plate.

In an alternative embodiment, the contoured surface may becircumferentially arcuate about the bore and the pivot member isrotatable about the head portion about the fastener insertion axis. Thepivot member may include a first locking feature that may correspond toand are engageable with a second locking feature on the plate. The firstlocking feature may include a ramped surface engageable with acorresponding shoulder on the sidewall of the aperture. The rampedsurface may be rotationally displaceable relative to the shoulder tolockingly engage the pivot member relative to the plate. The bore of thepivot member may include a sloped surface extending away from thelocking axis in a proximal direction. In turn, coordinated engagement ofthe ramped surface and the shoulder may urge the pivot member proximallyto lockingly engage the pivot member relative to the plate in responseto rotation of the pivot member in a first rotational direction. Theshoulder may include a lip for coordinated engagement of a trailing edgeof the ramped surface to restrict rotation of the pivot member in asecond rotational direction opposite the first rotational direction.

A sixth aspect includes a method of use of an orthopedic system. Themethod includes placing a plate body that extends between an uppersurface and a lower surface relative to a bone of a patient such thatthe lower surface is in contacting engagement with the bone of thepatient. The plate body comprises an aperture extending through theplate body from the upper surface to the lower surface along a referenceaxis. The method also includes advancing a fastener relative to theaperture along a fastener insertion axis. The reference axis and thefastener insertion axis define an included angle therebetween. Themethod also includes disposing a pivot member that is disposed about andpivotally displaceable relative to a head portion of the fastener fornon-removable engagement therewith within the aperture in response tothe advancing. The method also includes engaging a first locking featureon the pivot member with second locking features of the aperture tolockingly engage the fastener relative to the plate.

A number of feature refinements and additional features are applicableto the sixth aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of thesixth aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through fifth aspects maybe utilized in any combination with the sixth aspect.

For instance, the engaging may include rotating the pivot member inresponse to rotational advancement of the fastener. The engaging mayfurther include contacting the first locking feature comprising a rampedsurface with corresponding teeth on the plate to allow for rotation ofthe pivot member in a first direction relative to the plate andrestricting rotation in a second direction opposite the first directionin response to the engaging.

Alternatively the engaging may include rotation of the pivot memberindependently of the fastener member. In turn, the engaging may includeengaging the first locking feature that comprises a ramped surface witha corresponding shoulder on the sidewall of the aperture in response tothe rotation of the pivot member. The bore of the pivot member mayinclude a sloped surface extending away from the locking axis in aproximal direction. In turn, the method may include engaging the rampedsurface and the shoulder urges the pivot member proximally to lockinglyengage the pivot member relative to the plate in response to rotatingthe pivot member in a first rotational direction. A such, the method mayinclude restricting rotation of the pivot member in a second rotationaldirection opposite the first rotational direction with a lip on theshoulder for coordinated engagement of a trailing edge of the rampedsurface.

A seventh aspect include an orthopedic fastener assembly thatfacilitates variable angulation of the orthopedic fastener assembly whenused for fixation of a plate to a bone. The assembly includes a fastenerthat includes an elongate portion, a ledge, and a head portion. Theelongate portion is disposed at a distal portion of the fastener andincludes threads for engagement with a bone of a patient and extendingalong a fastener insertion axis. The ledge extends from the elongateportion radially relative to the fastener insertion axis. The headportion is disposed at a proximate portion of the fastener. The headportion is selectively displaceable relative to the elongate portion.The assembly also includes a pivot member that includes an expansionslot that allows for radial expansion of the pivot member radiallyrelative to the fastener insertion axis and a bore that defines alocking axis. The pivot member is disposed between the head portion andthe ledge such that the pivot member extends about the elongate portion.As such, the head portion is distally advanceable relative to the pivotmember to contact the pivot member with a ramp surface of the headportion to radially expand the pivot member upon the distal advancementof the head portion relative to the elongate portion.

A number of feature refinements and additional features are applicableto the seventh aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of theseventh aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through sixth aspects maybe utilized in any combination with the seventh aspect.

For instance, the head portion may be threadably engaged with a proximalportion of the elongate portion. This may facilitate relative movementbetween the head portion and the elongate portion. As such, the headportion may be distally or proximally displaced relative to the elongateportion in response to rotation of the head portion relative to theelongate portion.

In an embodiment, the proximal portion may include a first toolreceiving portion and the head portion may include a second toolreceiving portion. The first tool receiving portion may be engageablefor controllable rotation of the elongate member. As such, a first toolengaged with the first tool receiving portion may be used to rotatablyadvance the elongate portion relative to a bone of the patient.

The second tool receiving portion may be engageable for controllablerotation of the head portion. As such, a second tool may be engageablewith the second tool receiving portion to rotate the head portion foradvancement or retraction of the head portion relative to the elongateportion.

The pivot member may include an outer surface adapted for frictionalengagement with a sidewall of an aperture in a plate through which thefastener is advanceable upon radial expansion of the pivot member. Theaperture in the plate through which the fastener is advanceable maydefine a reference axis and the fastener insertion axis may bedisplaceable relative to the reference axis to define an included angle.The included angle between the reference axis and the fastener insertionaxis may be definable in at least one degree of freedom. The includedangle between the reference axis and the fastener insertion axis may bedefinable in at least two degrees of freedom. Moreover, the includedangle between the reference axis and the fastener insertion axis may bedefinable at any radial position about the reference axis. The includedangle between the reference axis and the insertion axis is at leastabout 15 degrees.

An eighth aspect includes an orthopedic system for fixation of anorthopedic plate to a bone of a patient. The system includes a platebody extending between an upper surface and a lower surface of the platebody. The system includes an aperture extending through the plate bodyfrom the upper surface to the lower surface along a reference axis. Theaperture has a sidewall extending circumferentially about an interior ofthe aperture. The system also includes a fastener that includes anelongate portion at a distal portion of the fastener comprising threadsfor engagement with a bone of a patient and extending along a fastenerinsertion axis. A ledge extends from the elongate portion radiallyrelative to the fastener insertion axis. Further still, a head portionis provided at a proximate portion of the fastener. The head portion isselectively displaceable relative to the elongate portion. The systemincludes a pivot member having an outer surface corresponding to thesidewall and comprising an expansion slot that allows for radialexpansion of the pivot member radially relative to the fastenerinsertion axis and a bore that defines a locking axis. The pivot memberis disposed between the head portion and the ledge such that the pivotmember extends about the elongate portion. In turn, the fastener isadvanceable relative to the aperture to dispose the pivot memberrelative to the sidewall and the head portion is distally advanceablerelative to the pivot member to contact the pivot member with a rampsurface of the head portion to radially expand the pivot member upon thedistal advancement of the head portion relative to the elongate portionto frictionally engage the sidewall with the outer surface to lockinglyengage the fastener relative to the plate.

A number of feature refinements and additional features are applicableto the eighth aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of theeighth aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through seventh aspectsmay be utilized in any combination with the eighth aspect.

For instance, in an embodiment, the aperture may include a neck portionwith a diameter less than the pivot member. In turn, the pivot membermay radially constrict when advanced relative to the neck portion of theaperture. The aperture may include a pocket distal to the neck portioncomprising the sidewall. As such, the pivot member may be disposed inthe pocket upon advancement of the fastener relative to the plate.

A ninth aspect includes a method of use of an orthopedic system. Themethod includes placing a plate body that extends between an uppersurface and a lower surface relative to a bone of a patient such thatthe lower surface is in contacting engagement with the bone of thepatient. The plate body comprises an aperture extending through theplate body from the upper surface to the lower surface along a referenceaxis. The method further includes advancing a fastener relative to theaperture along a fastener insertion axis. The reference axis and thefastener insertion axis define an included angle therebetween. Themethod also includes disposing a pivot member that is disposed between ahead portion and a ledge of the fastener for non-removable engagementtherewith within the aperture in response to the advancing. The methodincludes moving the head portion relative to the ledge and contacting aramped surface of the head portion with the pivot member. The methodalso includes radially expanding the pivot member in response to thecontacting and frictionally engaging a sidewall of the aperture with anouter surface of the pivot member in response to the radially expandingto lockingly engage the fastener to the plate.

A number of feature refinements and additional features are applicableto the ninth aspect. These feature refinements and additional featuresmay be used individually or in any combination. As such, each of thefollowing features that will be discussed may be, but are not requiredto be, used with any other feature or combination of features of theninth aspect. Moreover, any of the foregoing features or featurerefinements described in relation to the first through eighth aspectsmay be utilized in any combination with the ninth aspect.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of an embodiment of a pivot member and anorthopedic plate in an exploded state.

FIG. 2 is a perspective view of an embodiment of a pivot member.

FIG. 3 is a partial cross sectional view of an embodiment of a pivotmember in an exploded position relative to an aperture of a plate.

FIG. 4 is a partial cross sectional view of an embodiment of a pivotmember in retained engagement with a plate.

FIG. 5 is a partial cross sectional view of an embodiment of a pivotmember in retained engagement with a plate in a pivoted position.

FIG. 6 is a perspective view of an embodiment of a pivot member inretained engagement in a plate.

FIG. 7 is a perspective view of an embodiment of an orthopedic implantsystem comprising a pivot member in retained engagement with a plate inwhich a fastener is threadably engaged with the pivot member.

FIG. 8 is a partial cross sectional view of the embodiment of theorthopedic implant system as shown in FIG. 7.

FIG. 9 is a perspective view of an embodiment of an orthopedic implantsystem in which a fastener is in a fully advanced position relative to apivot member and a plate.

FIG. 10 is a partial cross sectional view of the embodiment of theorthopedic implant system as shown in FIG. 9.

FIG. 11 is a perspective view of an embodiment of an orthopedic implantsystem in which a plate is shown in phantom for clarity.

FIG. 12 is a perspective view of an embodiment of a fastener having apivot member retainedly engaged with a head portion of the fastener.

FIG. 13 is a partial cross sectional view of an embodiment of anorthopedic implant system in which a fastener passes through a plate topartially engage a bone of a patient.

FIG. 14 is a partial cross sectional view of the embodiment of FIG. 13with the fastener in a fully engaged position.

FIG. 15 is a detailed partial cross sectional view of an embodiment ofan orthopedic implant system depicting corresponding locking features ofa pivot member and a plate in spaced relation prior to engagementtherebetween.

FIG. 16 is a detailed partial cross sectional view of an embodiment ofan orthopedic implant system depicting corresponding locking features ofa pivot member and a plate in engagement.

FIG. 17 is a partial cross sectional view of an embodiment of anorthopedic implant system depicting a fastener in locked engagement witha pivot member and plate such that the fastener is disposed at an anglerelative to the plate.

FIG. 18 is a perspective view of an embodiment of an orthopedic implantsystem in which a fastener is in a partially advanced position relativeto a plate.

FIG. 19 is a perspective view of an embodiment of an orthopedic implantsystem in which a fastener is in a fully advanced position relative to aplate.

FIG. 20 is a partial cross sectional view of an embodiment of anorthopedic plate system in which a fastener is in a fully advancedposition relative to a plate and respective corresponding lockingfeatures on a pivot member and plate are disposed in non-lockingengagement.

FIG. 21 is a side view of the fastener and pivot member of theembodiment of FIG. 20 shown in isolation for clarity.

FIG. 22 is a partial cross sectional view of an embodiment of anorthopedic plate system in which a fastener is in a fully advancedposition relative to a plate and respective corresponding lockingfeatures on a pivot member and plate are disposed in locking engagement.

FIG. 23 is a side view of the fastener and pivot member of theembodiment of FIG. 22 shown in isolation for clarity.

FIG. 24 is a perspective view of an embodiment of an orthopedic platesystem in which a tool for disposing a pivot member in lockingengagement with the plate is disposed in relative relation to a pivotmember.

FIG. 25 is a perspective view of an embodiment of an orthopedic platesystem with a fastener member partially engage therewith.

FIG. 26 is a perspective view of an embodiment of an orthopedic platesystem with a fastener member advanced with respect thereto.

FIG. 27 is a perspective view of an embodiment of an orthopedic platesystem with a fastener member advanced with respect thereto and a headportion of the fastener member advanced to lockingly engage the pivotmember relative to a plate.

FIG. 28 is a cross sectional view of the embodiment of an orthopedicplate system as shown in FIG. 26 taken along a reference axis of theplate.

FIG. 29 is an alternate embodiment of a pivot member in retainedengagement with a plate.

DETAILED DESCRIPTION

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and are herein described in detail. It shouldbe understood, however, that it is not intended to limit the inventionto the particular form disclosed, but rather, the invention is to coverall modifications, equivalents, and alternatives falling within thescope of the invention as defined by the claims.

FIG. 1 depicts an embodiment of a pivot member 100 and a plate 200. Theplate 200 may include an aperture 202 extending between an upper surface204 of the plate 200 and a lower surface 206 of the plate. The aperture202 may be sized so as to receivingly engage the pivot member 100, whichis shown in an exploded state in FIG. 1. The aperture 202 may extendalong and define a reference axis 208.

With additional reference to FIG. 2, the pivot member 100 may include abore 102. The bore 102 may, in at least some embodiments, be threaded.In any regard, the bore 102 may define a fastener insertion axis 104along which a fastener (not shown in FIGS. 1 and 2) may be advancedrelative to the pivot member 100.

The pivot member 100 may comprise an expansion slot 106. The expansionslot 106 may define a gap or opening of the pivot member 100 thatextends along the entire pivot member 100 in a direction correspondingto (e.g., parallel with) the fastener insertion axis 104. Alternatively,the expansion slot 106 may not extend along the entire distance of thepivot member 100. For instance, the expansion slot 106 may only extendalong a portion of the distance of the pivot member 100 in a directioncorresponding to the fastener insertion axis 104. Moreover, in anembodiment that the expansion slot 106 does not extend entirely alongthe distance of the pivot member 100, a plurality of expansion slots 106may be provided radially about the pivot member 100. In any regard, theexpansion slot 106 may facilitated radial expansion of the pivot member100 relative to the fastener insertion axis 104.

In addition, the pivot member 100 may comprise an outer surface 108 thatis of a shape corresponding to a sidewall 210 of the aperture 202. Thesidewall 210 may extend circumferentially about the aperture 202. Inthis regard, can be seen in FIG. 3, the pivot member 100 may bealignable with and received in the aperture 202. When the aperture 202receives the pivot member 102, the outer surface 108 of the pivot member100 may be in conformal adjacent relation to the sidewall 210 of theaperture 202. For instance, as shown in FIG. 4, the pivot member 100 maybe received in the aperture 202 such that the outer surface 108 of thepivot member 100 is disposed in adjacent relation to the sidewall 210 ofthe aperture 202. With further reference to FIG. 5, the conformalcorresponding outer surface 108 and sidewall 210 may allow for pivotalmovement of the pivot member 100 relative to the aperture 202. In turn,the fastener insertion axis 104 and the reference axis 208 may bedisposed to define an included angle θ therebetween.

As may be appreciated, the pivot member 100 may be capable of pivotalmovement relative to the plate 200 in at least one degree of freedom todefine the included angle θ. In a preferred embodiment, the pivot member100 may be capable of pivotal movement relative to the plate 200 in atleast two degrees of freedom. In this regard, the included angle θ maybe defined at any radial position about the reference axis 208. That is,if considering the possible positions of the fastener insertion axis 104relative to the reference axis 208 as defining a field of possiblepositions, the fastener insertion axis 104 may be disposed in anyposition defining a cone extending along the reference axis 208. Inaddition, the plate 200 may comprise a skirted portion 220 that mayfacilitate acceptance of a fastener within the bore 102 when the pivotmember 100 is disposed at the included angle θ. In this regard, thepivot member 100 may be pivotal relative to the plate 200 such that theincluded angle θ is at least 10 degrees. In alternate embodiments, theincluded angle θ may be at least about 15 degrees.

With returned reference to FIG. 3, prior to insertion of the pivotmember 100 into the aperture 202, an extension 212 may extend from theupper surface 204 adjacent to the aperture 202. As shown in a firstconfiguration in FIG. 3, the extension 212 may be disposed to allow forthe pivot member 100 to be received in the aperture 202. Upon receipt ofthe pivot member 100 in the aperture 202, the extension 212 may bedisplaced toward the reference axis 208 as shown in FIGS. 4 and 5. Ascan be seen in particular in FIG. 5, the extension 212, when displacedafter the pivot member 100 is received in the aperture 202 may assist inretaining the pivot member 100 within the aperture 202. That is, whenthe pivot member 100 is pivoted relative to the aperture 202, theextension 212 may comprise a portion of the conformal, adjacent sidewall210 of the aperture 202 to retain the pivot member 100 within theaperture.

FIG. 29 depicts an alternate embodiment of a plate 200 having anextension 212 that extends parallel to the upper surface 204. In thisregard, the extensions 212 may define a hole 213 that has a smallercross dimension than the aperture 202. In this regard, the pivot member100 may be retracted or collapsed to allow for passage through the hole213. Once disposed in the aperture 202, the pivot member 100 may beexpanded such that the extension member 212 extending parallel to theupper surface 204 may restrict the pivot member 100 from being removedfrom the aperture 202.

In this regard, the pivot member 100 may be disposed in and retained bythe aperture 202. This arrangement may be established prior to the useof the plate 200 in a surgical operation. Because the pivot member 100is retained within the aperture 202, a surgeon or other user duringsurgery may not be required to manipulate the pivot member 100 todispose it relative to a fastener and/or the plate 200. In turn, theplate 200 may be provided as a unitary component to the surgeon for usein affixing the plate 200 to a bone of a patient without having theadded complexity of alignment and engagement of the pivot member 100relative to the plate 200.

In an embodiment, the outer surface 108 of the pivot member 100 may benoncircular. In corresponding relation, the sidewall 210 of the aperture202 may also have at least a portion that is non-circular. In thisregard, the outer surface 108 and the sidewall 210 may interface torestrict rotation of the pivot member 100 relative to the aperture 202.For instance, the pivot member 100 may comprise a plurality of flats 110that correspond to flat portions 214 of the aperture 202 as can be seenin FIG. 6. Chamfers 114 may be provided between the flats 110 as canbest be seen in FIGS. 2-5. The chamfers 114 may assist in facilitatingpivoting of the pivot member 110 relative to the aperture 202 (e.g., toprovide two degrees of freedom of movement of the pivot member 100relative to the plate 200 as described above).

In addition, the pivot member 100 may include a convex portion 112. Theconvex portion 112 may be in conformal adjacent relation to a rampedsurface 216. The ramped surface 216 may extend along a flange 218 thatextends from the sidewall 210 toward the reference axis 208. In thisregard, the flange 218 and ramped surface 216 may comprise a bowledportion that receives the convex portion 112 of the pivot member 110when the pivot member 100 is disposed in the aperture 202.

With further reference to FIG. 7, an embodiment of a fastener 300 isshown relative to the pivot member 100 and plate 200. The pivot member100, plate 200, and fastener 300 may comprise an orthopedic implantsystem 10. The fastener 300 may comprise a screw such as a surgicalscrew or the like. The fastener 300 may comprise a self-tapping screw,or include any other features common to surgical screws. The fastener300 may comprise an elongate portion 302 at a distal portion of thefastener 300 and a head portion 304 at a proximal portion of thefastener 300. The elongate portion 302 may comprise threads 306. In thisregard, the fastener 300 may be in threaded engagement withcorresponding threads disposed about the bore 102 of the pivot member100. In addition, the threads 306 of the fastener 300 may be used toadvance the fastener 300 relative to a bone of a patient for securingthe fastener 300 to the bone after having passed through the pivotmember 100 and plate 200.

The head portion 304 may also comprise threads 308. The threads 308 maybe the same pitch as the threads 306 of the elongate portion 302. Inaddition, the threads 308 on the head portion 304 may comprise a doublethread. In this regard, two threads of the same pitch may be provided onthe head portion 304. In this regard, the pitch of the threads 306 ofthe elongate portion 302 may be the same as the pitch of the threads 308of the head portion 304 with the head portion 304 featuring a doublethread. Both threads 306 and 308 may engage with the threads of the bore102, or threads 308 on the head portion 304 alone may engage the threadsof the bore 102. In this latter regard, the threads 306 on the elongateportion 302 may be provided to engage the bone of a patient, yet may notcontact the pivot member 100 as the fastener 300 is advanced relativethereto. The head portion 304 may have a sloped surface that defines aprofile such that the diameter of the head increases toward the proximalend of the fastener 300. For instance, the head portion 304 may befrustoconical. In any regard, the pitch diameter of the fastener 300 mayincrease toward the proximal end of the fastener 300.

In turn, the interaction of the fastener 300 may result in locking ofthe pivot member 100 relative to the plate 200. Specifically, asdescribed above, the pivot member 100 may be expandable radially inrelation to the fastener insertion axis 104. For instance, theinteraction of the fastener 300 (e.g., the head portion 304 thereof) asit is advanced relative to the pivot member 100 may cause the radialexpansion of the pivot member 100. In turn, the outer surface 108 of thepivot member 100 may frictionally engage the sidewall 212 of theaperture 202. The frictional engagement of the outer surface 108 withthe sidewall 210 may at least limit, and in some instances prevent,movement of the pivot member 100 relative to the plate 200.

In some embodiments, the threaded engagement of the threads 308 of thehead portion 304 of the fastener 300 may act on the bore 102 to radiallyexpand the pivot member 100 relative to the aperture 202 to from a firstconfiguration as shown in FIG. 6 to a second configuration as shown inFIGS. 9 and 10. In the first configuration, the outer surface 108 may bemoveable relative to the conformal adjacent sidewall 210 of the aperture202. However, in the second configuration, the outer surface 108 of thepivot member 100 may contactingly engage the sidewall 210.

Upon advancement of the fastener 300 relative to the pivot member 100,the head portion 304 may threadingly engage the bore 102 of the pivotmember 100. As the head portion 304 may have an increased diameter ascompared to the elongate portion 302 (e.g., including potentiallyincluding a frustoconically shaped portion with increasing diameteralong the head portion 304 in a proximal direction), the engagement ofthe head portion 304 with the pivot member 100 may expand the pivotmember 100 radially relative to the fastener insertion axis 104 to thesecond configuration as shown in FIGS. 9 and 10. That is, the secondconfiguration of the pivot member 100 may be at a greater radialexpansion than that of the first configuration.

In the second configuration, the outer surface 108 of the pivot member100 may engage the sidewall 210 of the aperture 202 to restrict movementof the pivot member 100 relative to the plate 200. In this secondconfiguration, the movement of the pivot member 100 relative to theplate 200 may be fully restricted such that forces imparted by asurgeon, forces resulting from installation of the plate 200 to the boneof a patient, or forces that are imparted to the pivot member 100, plate200, and fastener 300 once installed do not result in movement of thepivot member 100 relative to the plate 200. In an embodiment, the headportion 304 threadably engages the bore 102 when the head portion 304 isadvanced to the pivot member 100. In this regard, the fastener 300 maybe rigidly engaged with the pivot member 100 that is in turnfrictionally engaged with the aperture 202.

In other embodiments, the conical or frustoconical shape of a headportion 304 without threads may also be used. In this embodiment, theadvancement of the fastener 300 relative to the bone of a patient maycause compressive forces to act on the pivot member 100 such that thefrustoconical head portion 304 still results in radial expansion of thepivot member 100 to frictionally engage the aperture 202 as illustratedin FIG. 9. Accordingly, the fastener 300 may be lockingly engageablewith the pivot member 100 by threaded interaction therebetween such thatthe fastener 300 is in turn loaded without compression forces actingbetween the fastener 300 and the plate 200. In contrast, the fastener300 may lacking locking threads to lock the fastener 300 to the pivotmember 100 such that the fastener 300 may be loaded in compression tolock the pivot member 100 relative to the plate 200.

FIG. 11 depicts another embodiment of an orthopedic implant system 20.The system 20 includes a plate 400, a pivot member 500, and a fastener600. Unlike the system 10 described above in which the pivot member 100is retainedly engaged with the plate 400 within the aperture 202, system20 may include a fastener 600 that retains the pivot member 500therewith. In this regard, the pivot member 500 may pivot relative tothe fastener 600 and may provide angulation of the fastener 600 whilestill allowing the pivot member 500 to be lockingly engaged with theplate 400 as will be described in greater detail below.

The plate 400 includes an aperture 402. As shown in FIG. 11, thefastener 600 includes the pivot member 500 in retained engaged relationto a head portion 602 of the fastener 600. In this regard, the fastener600 may pass through the aperture 402 such that the pivot member 500engages the plate 400. When engaged with the plate 400, the fastener 600and pivot member 500 may be lockingly engaged to restrict or preventmovement between the plate 400, pivot member 500 and fastener 600.

With additional reference to FIG. 12, the pivot member 500 may comprisea bore 502. The bore 502 may comprise a non-circular sidewall 504 thatat least partially defines the bore 502. The head portion 602 may havean outer surface 604 that is correspondingly non-circular relative tothe sidewall 504. In this regard, upon rotation of the fastener 600, thepivot member 500 may undergo corresponding rotational movement byinteraction of the sidewall 504 and the outer surface 604. As can bestbe seen in FIG. 17, the outer surface 604 of the head portion 602 may bein conformal adjacent relation to the sidewall 504 of the bore 502. Theouter surface 604 and the sidewall 504 may be curved to allow pivotalmovement between the fastener 600 and the pivot member 500.Specifically, the pivot member 500 may define a reference axis 506 aboutwhich the bore 502 extends. The fastener 600 may extend along a fastenerinsertion axis 606. Accordingly, the pivotal movement between thefastener 600 and the pivot member 500 may define an included angle θtherebetween.

The included angle θ in the system 20 may include any of thecharacteristics described above in relation to system 10. That is, theincluded angle θ may be defined at any radial position about thereference axis 606. In addition, the included angle θ may be at leastabout 10 degrees in an embodiment or even at least about 15 degrees.

With reference to FIG. 13, the fastener 600 may be advanced through theaperture 402 of the plate 400. For instance, while not shown in FIG. 13,the elongate portion 604 of the fastener 600 may be advanced into thebone of a patient. As the fastener 600 is advanced relative to the plate400, the head portion 602 may be advanced toward the plate 400 such thatthe pivot member 500 may be disposed within the aperture 402. FIG. 15shows the fastener 600 is in position such that a portion of the pivotmember 500 is disposed with in the aperture 402 of the plate 400.

As can best be seen in FIG. 15, the pivot member 500 comprises a firstlocking feature on a distal portion thereof. The aperture 402 comprisesa second locking feature on a proximal-facing portion of the aperture402. The first locking feature on the pivot member 500 may correspond tothe second locking feature of the aperture 402 so that the first lockingfeature and the second locking feature are engageable for lockinginteraction therebetween.

Specifically, the first locking feature of the pivot member 500comprises a plurality of ramped surfaces 506. The second locking featureof the aperture 402 comprises a plurality of teeth 408. As the fastener600 is advanced relative to the bone of a patient, the fastener 600 alsomoves distally relative to the plate 400. Because the pivot member 500is retained by the head portion 602 of the fastener 600, the distalmovement of the fastener 600 brings the ramped surfaces 506 in contactwith the teeth 408. As the fastener 600 is rotated, the ramped surfaces506 travel along the teeth 408 in a ratcheting action as the fastener600 is advanced. Upon continued advancement of the fastener 600, theteeth 408 will interlockingly engage the ramped surfaces 506 as shown inFIG. 16. The interlocking engagement between the ramped surfaces 506 andthe teeth 408 may restrict rotation of the fastener 600 in a directionopposite the direction in which the fastener 600 is rotated as it isadvanced.

In this regard, as the fastener 600 is advanced relative to the plate400, the pivot member 500 is clampingly engaged in the aperture 402 bythe head portion 602 of the fastener 600. Moreover, the interlockingengagement of the ramped surfaces 506 and the teeth 408 restrictrotation of the fastener 600 tending to withdraw the fastener 600proximally. As such, the fastener 600 remains clampingly engaged withthe plate 400. Moreover, the compressive forces acting between thefastener head 602 and the pivot member 500 create frictional engagementbetween the outer surface 604 of the head portion 602 and the sidewall504 of the bore 502. In turn, the included angle θ defined between thefastener insertion axis 606 and the reference axis 506 is maintained asfurther pivotal movement between the head portion 602 and the pivotmember 500 is restricted or prevented based on the frictionalinteraction between the sidewall 504 and the outer surface 604. Byrestricted from pivotal movement, it is meant that the forcesexperienced during bone healing or movement by the patient will notcause such pivotal movement. That is, application of a large force(e.g., by a surgeon with assistance of a tool or the like) may be ableto cause such pivotal movement to remove the hardware during a surgicalprocedure.

With further reference to FIGS. 18 and 19, another embodiment 22 of anorthopedic implant system 22 is shown. The system 22 comprises a plate450, a pivot member 550, and a fastener 650. Like in the embodiment ofthe orthopedic implant system 20 described above, the pivot member 550may be retainedly engaged with a head portion 652 of the fastener 600.In this regard, the pivot member 550 may pivot relative to the fastener650. The pivot member 550 may define a bore 552 that may extend along areference axis. The fastener 650 may extend along a fastener insertionaxis. In turn, the pivotal movement of the pivot member 550 relative tothe fastener 650 may define an included angle between the reference axisand the fastener insertion axis as described above in relation to thesystem 20.

Specifically, the head portion 652 may comprise an outer surface 654.Additionally, the bore 552 may comprise a sidewall 554. The outersurface 654 may be disposed in conforming adjacent relation to thesidewall 554. In the embodiment of the system 22, the outer surface 654may be arcuate both circumferentially about the fastener insertion axisand at least partially arcuate along the fastener insertion axis. Thatis, the outer surface 654 may be at least partially spherical. In turn,the sidewall 554 may be conformingly shaped relative to the outersurface 654 such that the sidewall 554 may be at least partiallyspherical as well. In turn, the pivot member 550 may pivot relative tothe head portion 652.

In turn, the fastener 600 may be advanced relative to the plate 450 suchthat the pivot member 552 is disposed within an aperture 452 of theplate 450 that extends from an upper surface 454 to a lower surface 456of the plate 450. As can best be seen in FIG. 20, when the pivot member550 is disposed in the aperture 452, a first locking feature of thepivot member 550 may be disposed relative to a second locking feature ofthe plate 400. Specifically, the pivot member 550 may comprise a rampedsurface 556. This is more clearly seen in FIG. 21, which depicts theposition of the pivot member 550 in FIG. 20 without the plate 450 shownfor clarity.

As can be appreciated, a plurality of ramped surfaces 556 may also beprovided without limitation. The aperture 452 comprises one or moreshoulders 458. As such, when the fastener 650 is advanced relative tothe plate 450 (e.g., by advancing a threaded elongate portion 654 of thefastener 650 into a bone of a patient), the pivot member 550 that isretained at the head portion 652 may be advanced relative to theaperture 452. The advancement of the fastener 650 may include rotationin a first direction (e.g., clockwise). When the fastener 650 is fullyadvanced, the pivot member 550 may be disposed such that the rampedsurfaces 556 are not contacting the shoulder 458 as shown in FIG. 20.

In turn, rotation of the pivot member 550 in a second direction oppositethe first direction (e.g., counterclockwise) may cause the rampedsurfaces 556 to engage the shoulder 458 as shown in FIG. 22. FIG. 23depicts the position of the pivot member 550 in the absence of the plate450 for clarity. Specifically, the ramped surfaces 556 may slidinglyengage the shoulder 458, which may be inclined in corresponding relationto the ramped surfaces 556. IN turn, the ramped surfaces 556 mayslidingly engage to ride up the shoulder 458. This may cause the pivotmember 550 to be urged away from the plate 450. As the fastener 650 maybe captured in the bone of the patient, the urging of the pivot member550 away from the plate 450 may clampingly engage the plate 450 with thebone of the patient. Moreover, the pivot member 550 may impart aclamping force on the head portion 652 of the fastener 650. The clampingforce acting between the pivot member 550 and the fastener 650 mayresult in frictional engagement of the sidewall 454 of the aperture 452with the outer surface 654 of the head portion 652. This frictionalengagement may maintain the position of the fastener 650 relative to thepivot member 550.

Additionally, the shoulder 458 may include a lip 460. The lip 460 may bedisposed such that a trialing edge 462 of the ramped surface 556 maypass over the lip 460. In this regard, the ramped surface 556 may bedisposed relative to the lip 460 such that rotation of the pivot member550 in the first direction (i.e., tending to cause the pivot member tounclamp the plate 450 and fastener 650) may be restricted by the lip460. Accordingly, the pivot member 550 may be restricted, and in someinstances prevented, from relative movement with respect to the fastener600. As stated above, restricted relative movement may includeprevention of such movement during bone healing or normal patientactivities, but could be overcome by the force applied by a surgeonusing a tool to remove the fastener 600.

With further reference to FIG. 24, the rotation of the pivot member 550in the second direction may be induced by interaction with a tool 700.For instance, the tool 700 may comprise projections 702 thatcorrespondingly engage slots 704 provided on the pivot member 550. Inthis regard, the tool 700 may be engaged with the pivot member 550 suchthat the projections 702 engage the slots 704. In turn, the tool 700 maybe used to rotate the pivot member 550 to engage the ramped surfaces 556with the shoulder 458 to impart the clamping forces as described above.

With further reference to FIGS. 25-28, another embodiment of anorthopedic plate system is depicted. The system depicted in FIGS. 25-28may include a plate 900 having a bore 902 extending from a top surface904 to a bottom surface 906 of the plate 900. A fastener 850 may beprovided that may pass through the bore 902 to engage the bone of thepatient for fixation of the plate 900 relative to the bone of thepatient. A pivot member 800 may be secured relative to a head portion810 of the fastener 850. As will be described in greater detail below,the pivot member 800 may be disposed between a head portion 810 and aledge 814 that extends radially from the fastener 850. In any regard, asthe fastener 850 is advanced relative to the bone of the patient, thepivot member 800 may become disposed within the aperture 902 of theplate 900. Thereafter, the pivot member 800 may be selectively radiallyexpanded to lockingly engage the plate 900.

The fastener 850 may include an elongate portion 812. The elongateportion 812 may comprise threads 818 that are engageable with the boneof the patient to advance the fastener 850 relative to the bone of thepatient. The fastener 850 may include the head portion 810 which isdisposed near a proximal end portion 824 of the fastener 850. The headportion 810 may be threadably engaged with the proximal end portion 824of the fastener 850. Accordingly, the head portion 850 may be advanceddistally or retracted proximally by corresponding respective rotation ofthe head portion 850 relative to the proximal end portion 824 of thefastener 850. The ledge 814 briefly described above may extend radiallyrelative to a fastener insertion axis 804 that generally extends alongthe elongate portion 812. The ledge 814 may be extend about the fastener850 circumferentially such that the ledge 814 defines a stop such thatthe pivot member 800 may not be advanced distally relative to the ledge814.

As shown in FIG. 25, the pivot member 800 may be arranged such that thepivot member 800 is disposed between the head portion 810 and the ledge814 to retainedly engaged the pivot member 800 therebetween. As may beappreciated, the pivot member 800 may be relatively easily disposedbetween the head portion 810 and the ledge 814 by removing the headportion 810 from the proximal end portion 824 of the fastener 850.Thereafter, the pivot member 800 may be disposed about the fastener 850such that the fastener 850 extends relative to a bore 802 defined by thepivot member 800. The head portion 810 may be reengaged with theproximal end portion 824 by way of the threadable engagement providedtherebetween. The engagement of the pivot member 800 relative to thefastener member 850 may be performed prior to a surgeon utilizing thefastener 850 to secure the plate 900 relative to the patient. As such,the fastener 850 with the pivot member 800 disposed relative thereto maybe provided for use by a surgeon as an integral unit or preconfiguredsubassembly such that the utilization of the fastener 850 and pivotmember 800 are efficient to the surgeon.

The proximal end portion 824 may include a first tool receiving portion816. For instance, the first tool receiving portion 816 may comprise ahexagonally shaped recess that may accept a correspondingly hexagonallyshaped tool portion. Other configurations of the first tool receivingportion 816 may be provided that allow for controllable rotation of theelongate portion 812 of the fastener 850.

The head portion 810 may include one or more second tool receivingportions 822. For instance, as shown in FIG. 25 the second toolreceiving portions 822 may include cylindrical recesses provided in thehead portion 810. The second tool receiving portions 822 may bedistributed radially about the proximal portion of the head portion 810such that the second tool receiving portions 822 are accessible from theproximal portion of the fastener 850. It may be appreciated that otherconfigurations of the second tool receiving portions 822 may beprovided. Specifically, any configuration that allows for engagement bya tool for controlled rotation of the head portion 810 may be providedwithout limitation.

In this regard, the first tool receiving portion 816 may be engaged by atool portion that may in turn impart rotation of the fastener 850 aboutthe fastener insertion axis 804. This may in turn caused threads 818 toengage the bone of the patient and be advanced relative thereto. Duringthe rotational advancement of the fastener 850 the second tool receivingportions 822 may be engaged and correspondingly rotated to preventrelative rotation between the head portion 810 and the proximal endportion 824 of the fastener 850. Alternatively, the first tool receivingportion 816 may be engaged alone to advance the fastener 850. In thisregard, the head portion 810 may correspondingly rotate with theproximal end portion 824 absent engagement with the second toolreceiving portions 822.

In any regard, as the fastener 850 is advanced relative to the plate900, the pivot member 800 that may be restrainedly engaged between thehead portion 810 and the ledge 814 may also be advanced relative to theplate 900. Specifically, the pivot member 800 may be advanced so that itis disposed within the aperture 902 of the plate 900. The aperture 902of the plate 900 may include a neck portion 912. The pivot member 800may also include an expansion slot 806 that allows for radial expansionand contraction of the pivot member 800 relative to the fastenerinsertion axis 804. In this regard, as the fastener 850 is advancedrelative to the plate 900, the pivot member 800 may engage the neckportion 912. Upon further advancement of the fastener 850, the pivotmember 800 may be radially compressed such that the pivot member 800 apass by the neck portion 912 into a pocket 914 of the aperture 902. Thepocket 914 may be a spheroid shaped portion comprising a sidewall 910 ofthe aperture 902. This configuration in which the pivot member 800 isdisposed in the pocket 914 of the aperture 902 shown in FIG. 26.

The head portion 810 may be engaged at the second tool receiving portion822 to impart rotation of the head portion 810 relative to the proximalend portion 824 to advance the head portion 810 distally relative to theproximal end portion 824. As can best be appreciated collectively inFIGS. 27 and 28, the distal advancement of the head portion 810 maycause a ramped surface 820 of the head portion 810 to engage the bore802 of the pivot member 800. In turn, the distal advancement of the headportion 810 may cause the ramped surface 822 cause the radial expansionof the pivot member 800 such that an outer surface 808 of the pivotmember 800 frictionally engages the sidewall 910 of the pocket 914.Accordingly, the pivot member 800 may be lockingly engaged relative tothe plate 900 by way of advancement of the head portion 810 relative tothe proximal end portion 824 so as to urge the pivot member 800 andradial expansion against the sidewall 910.

As in the previous embodiments, the fastener 850 may be insertedrelative to the plate such that an angle θ is included between thefastener insertion axis 804 and the reference axis 908. Upon advancementof the head portion 810 distally relative to the proximal end portion824 of the fastener 850, the fastener may be lockingly engaged relativeto the plate at the angle θ. As in the foregoing embodiments, the angleθ may be at least about 15°.

When utilizing the embodiment depicted in FIGS. 25-28, one or more toolsmay be provided for engagement of the first tool receiving portion 816and the second tool receiving portion 822. For example, a singleintegral tool may be provided that includes a corresponding first toolportion adapted for engagement of the first tool receiving portion 816and a corresponding second tool portion adapted for engagement of thesecond tool receiving portions 822. The second tool portion may bemovable relative to the first tool portion such that a user may chooseto utilize the first tool portion alone, the second tool portion alone,or the first and second tool portions together. That is, the tool mayallow for selective engagement of the first, second, and/or first andsecond tools with the respective tool receiving portion. Alternatively,a discrete first tool having a first tool portion corresponding to thefirst tool receiving portion 816 may be provided and a discrete secondtool having a second tool portion corresponding to the second toolreceiving portions 822 may be provided. In this regard, the first toolmay be utilized to advance the fastener 850 into the position shown inFIG. 26. The first tool may be disengaged from the first tool receivingportion 816. The second tool may then be engaged with the second toolreceiving portions 822 to rotate the head portion 810 relative to theproximal end portion 824 to distally advance the head portion 810causing radial expansion of the pivot member 800.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, such illustration and description isto be considered as exemplary and not restrictive in character. Forexample, certain embodiments described hereinabove may be combinablewith other described embodiments and/or arranged in other ways (e.g.,process elements may be performed in other sequences). Accordingly, itshould be understood that only the preferred embodiment and variantsthereof have been shown and described and that all changes andmodifications that come within the spirit of the invention are desiredto be protected.

1.-45. (canceled)
 46. An orthopedic fastener assembly for use infixation of an orthopedic plate to a bone of a patient, the assemblycomprising: a fastener comprising: an elongate portion on a distalportion of the fastener comprising threads for engagement with a bone ofa patient, and a head portion at a proximate portion of the fastener;and a pivot member comprising a bore having a contoured surface disposedabout and pivotally displaceable relative to the head portion forpivotal articulation of the pivot member about the head portion, whereinthe pivot member is moveable relative to the head portion and securedthereto to prevent removal of the pivot member from the head portion.47. The orthopedic fastener assembly of claim 46, wherein the pivotmember comprises engagement features to lockingly engage the pivotmember to a plate through which the fastener has been advanced.
 48. Theorthopedic fastener assembly of claim 47, wherein the bore defines areference axis and the fastener extends along a fastener insertion axis,and wherein the pivotal articulation of the pivot member about the headportion defines an included angle between the reference axis and thefastener axis.
 49. The orthopedic fastener assembly of claim 48, whereinthe included angle between the reference axis and the fastener insertionaxis is definable at any radial position about the reference axis. 50.The orthopedic fastener assembly of claim 49, wherein the included angleis at least about 10 degrees.
 51. The orthopedic fastener assembly ofclaim 50, wherein the included angle is at least about 15 degrees. 52.The orthopedic fastener assembly of claim 48, wherein the contouredsurface and the head portion are non-circular and interface to restrictrotation of the pivot member about a fastener insertion axis extendingalong the elongate portion.
 53. The orthopedic fastener assembly ofclaim 52, wherein the pivot member comprises a first locking featurethat correspond to and are engageable with a second locking feature on aplate through which the fastener is advanceable.
 54. The orthopedicfastener assembly of claim 53, wherein the first locking featurecomprises a ramped surface engageable with corresponding teeth on aplate through which the fastener is advanceable to allow for rotation ofthe pivot member in a first direction relative to the plate and torestrict rotation in a second direction opposite the first directionwhen the ramped surface engages the corresponding teeth on the plate.55. The orthopedic fastener assembly of claim 48, wherein the contouredsurface is circumferentially arcuate about the bore and the pivot memberis rotatable about the head portion about the fastener insertion axis.56. The orthopedic fastener assembly of claim 55, wherein the pivotmember comprises a first locking feature that correspond to and areengageable with a second locking feature on a plate through which thefastener is advanceable.
 57. The orthopedic fastener assembly of claim56, wherein the first locking feature comprises a ramped surfaceengageable with a corresponding shoulder on a sidewall of an apertureextending through a plate through which the fastener is advanceable,wherein the ramped surface is rotationally displaceable relative to theshoulder to lockingly engage the pivot member relative to the plate. 58.The orthopedic fastener assembly of claim 57, wherein the bore of thepivot member comprises a sloped surface extending away from the lockingaxis in a proximal direction, and coordinated engagement of the rampedsurface and the shoulder urges the pivot member proximally to lockinglyengage the pivot member relative to the plate in response to rotation ofthe pivot member in a first rotational direction.
 59. The orthopedicfastener assembly of claim 58, wherein the shoulder comprises a lip forcoordinated engagement of a trailing edge of the ramped surface torestrict rotation of the pivot member in a second rotational directionopposite the first rotational direction. 60.-104. (canceled)